BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3910680 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12299
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN SCREW / UNKNOWN LOT. EXPLANT DATE: UNKNOWN DATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: "PSS 3D" HEAD IS DETACHED FROM THE SCREW HEAD. A REVIEW OF THE ACCOMPANYING X-RAY INDICATES THAT THERE APPEARS TO BE A HEAD DETACHED FROM THE SCREW HEAD AT THE CAUDAL OF THE TWO LEVELS OF THE CONSTRUCT. A PICTURE OF THE SCREW WITH THE HEAD DETACHED, ALONG WITH THE PROVIDED X-RAY, INDICATES THAT THE SCREW WAS EXPLANTED. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386370 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention